Formula Use

While breast milk is recommended for infants in most situations,
formula is often used in infancy when breast
milk is not available or contraindicated. Formula can also be given to older children who are
unable to obtain adequate nutrition through conventional means. Formula comes in 3
different forms:

Ready to feed (does not need to be prepared with water)

Powdered (must be mixed with water, but is the least expensive form)

Concentrated liquid

Delivery of formula can
involve use of a cup, spoon, supplemental nursing
system, bottle, or feeding tube (see Feeding Tubes and Gastrostomies). The nutritional content of formula is regulated by the U.S. Food & Drug Administration based on recommendations by the Committee on Nutrition (AAP). Nutritional
requirements, digestive concerns, metabolic demands, and age of the child drive the selection of one
formula over another. Background information on the many types
of formulas available and detailed information about the different
components of formula and the rationale for their use are presented below.

The links, below, lead to charts that list the major brands of formula and key differences among their ingredients.

Pearls and Alerts

When to stop preterm formula: Preterm infant formula and human milk fortifiers are designed to meet the increased
vitamin and mineral needs of the preterm infant consuming smaller volumes than the term
infant consumes. Continuation of the preterm infant formula and human milk fortifiers in
infants who weigh more than 2.5-3.0 kg will result in increased intakes of several
vitamins, including vitamins A and D. Case reports of hypervitaminosis D suggest that
these products should be discontinued when the infant is exceeding the recommend
intakes for fat-soluble vitamins.

Formula feeding contraindications: These include vomiting or spit-up associated with inadequate weight
gain, colic, constipation or diarrhea, blood or mucus in
stool, severe or difficult to treat
eczema, hives, and anaphylaxis.

Aluminum toxicity: Preterm infants and infants that were intrauterine growth restricted who use soy formula may be at risk of aluminum toxicity.
[Fanni: 2014]

Formula Components

Six basic components compose formula - protein, fat, carbohydrate, vitamins, minerals, and
other nutrients. What makes one brand of formula different from the next is the specific
carbohydrates, fats, and proteins it uses, as well as any additional ingredients.
These differences
and their indicated use are explained below. The Medical
Home Portal does not endorse a
specific brand or preparation; however, commercially prepared formulas will be mentioned here
to provide examples. International recommendations for formula composition can be found at [Koletzko: 2005].

PROTEIN

Cow milk protein. Cow milk proteins include whey and casein. While whey and casein are also in human milk, there are differences between the
whey in human milk and the whey in cow milk. Protein content of cow milk based formulas tends to be higher than in human milk
and can result in increased amino acid levels (of unclear clinical significance). [Committee: 2013] Infants with documented cow milk, protein-induced enteropathy or enterocolitis frequently are as sensitive to soy protein
and should not be given isolated soy protein based formula routinely. They should be provided formula derived from hydrolyzed
protein or synthetic amino acid. [Jatinder: 2008]

Indications for use: Typically, first line replacement for breastmilk

Examples: Similac Advance, Enfamil LIPIL, many store brand formulas

Soy protein. The protein is a soy isolate supplemented with L-methionine, L-carnitine, and taurine to provide a protein content of 2.45-2.8
g per 100 kcal, or 1.65-1.9 g/dL. Approximately 10-14% of infants with an allergy to cow milk protein will also have allergy
to soy protein. [Committee: 2013] This proportion can be up to 60% higher in infants with proctitis or enterocolitis as a result of protein intolerance.
Concerns raised in relation to phytoestrogens/isoflavones include their potential negative effects on sexual development and
reproduction, neurobehavioral development, immune function, and thyroid function; although studied by numerous investigators
in various species, there is no conclusive evidence that
dietary soy isoflavones may adversely affect human development, reproduction, or endocrine function. [Jatinder: 2008] Epidemiologic studies have suggested a protective effect of isoflavones against a number of adult chronic diseases, including
coronary heart disease and breast, endometrial, and prostate cancers. [Jatinder: 2008]

Indications for use: Galactosemia, hereditary lactase deficiency, IgE mediated allergy to cow milk, vegetarian, secondary lactose intolerance
related to acute gastroenteritis.
Soy protein based formulas are not designed or recommended for preterm infants who weigh <1800 g. [Committee: 2013] The routine use of isolated soy protein based formula has no proven value in the prevention or management of infantile colic,
or prevention of atopic disease. [Jatinder: 2008]

Examples: Isomil, ProsoBee, Nestle/Gerber Good Start Soy

Partially hydrolyzed protein. Cow milk proteins (whey and/or casein) are broken into portions, making them somewhat easier to digest. Some formulas add
probiotics and/or omega-3 and -6. It should be noted that the FDA concluded there is little evidence to support the relationship
between intake of partially hydrolyzed 100% whey protein infant formula (W-PHF) and a reduced risk of atopic dermatitis in
partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. [Carolyn: 2012] In addition, the FDA requires a warning statement to indicate that partially hydrolyzed infant formulas are not hypoallergenic,
and they should not be fed to infants who are allergic to milk or have existing milk allergy symptoms. [Carolyn: 2012]

Indications for use: Prevention of atopic dermatitis, but not for infants with cow milk protein intolerance

Examples: Nestle/Gerber (aka Carnation) Good Start products

Extensively hydrolyzed protein. Through a heat and enzymatic process, casein is broken into small portions (peptides and amino acids), which are then generally
not recognized by the body as an allergen. Taste and cost can be a limiting factor for use.

Amino acid based protein (aka Elemental). Taste and cost can be a limiting factor for use.

Indications for use: When extensively hydrolyzed formulas are not tolerated and there is extreme protein hypersensitivity.

Examples: Enfamil PurAmino, Nutricia Neocate

FAT

Typically, almost half of the calories in cow milk based formulas are from fat that is formulated to provide an appropriate
and absorbable blend of essential fatty acids. The fat is usually derived from vegetable oils such as palm olein, soy, coconut,
high-oleic sunflower or safflower, plus occasionally animal fats. [Committee: 2013] Many formulas include added long-chain poly-unsaturated ARA and DHA omega fatty acids. The sources of these are single cell
organisms.

Medium chain triglycerides. Some formulas contain increased medium chain triglycerides and other features making it more readily digestible.

Indications for use: For fat malabsorption, such as in short bowel syndrome, cystic fibrosis, and intractable diarrhea

Example: Pregestimil

Long chain triglycerides (ketogenic). Provides 3-4 grams of fat for every 1 gram of carbohydrate and protein. The kinds of foods that provide fat for the ketogenic
diet are butter, heavy whipping cream, mayonnaise, and oils (e.g., canola or olive). See Ketogenic Diet for more information.

Indications for use: For children whose seizures have not responded to several different seizure medicines: Only for use in close consultation
with a neurologist. Usually, dieticians recommend a daily diet that contains 75-100 calories for every kilogram (2.2 pounds)
of body weight and 1-2 grams of protein for every kilogram of body weight. [Epilepsy: 2014]

Examples: Nutricia KetoCal, Solace KetoVolve

CARBOHYDRATE

Lactose is the main carbohydrate in human milk as well as in many formulas. It breaks down to glucose and galactose. Corn
maltodextrin is sometimes used as a secondary source of carbohydrate in formula. Complex carbohydrates, also known as starches,
are used in some formulas as thickeners to help with gastroesophageal reflux.

Alternatives to lactose. These include sucrose, corn syrups, tapioca starch, maltodextrins, and other modified starches.

Indications for use: Congenital lactase deficiency, which is rare, and lactose
intolerance (not a common infant condition)

Iron: Quantities vary in
different types of formulas to adjust for absorption.
Standard infant formulas contain 10-12 mg/L. Low-iron formulas contain 4-6 mg/L, but are not routinely recommended.
Caregivers may be concerned that the iron upsets their infant's stomach or causes
constipation, but no scientific evidence demonstrates this effect. [Committee: 2013]

Aluminum: Although the aluminum content of human milk is 4-65 ng/mL, soy
protein based formula is 600-1300 ng/mL. [Jatinder: 2008] Because aluminum competes
with calcium for absorption, increased amounts of dietary aluminum from isolated soy
protein based formula may contribute to the reduced skeletal
mineralization (osteopenia)
observed in preterm infants and infants with intrauterine
growth retardation.
[Jatinder: 2008]
Term infants with normal renal function do not seem to
be at substantial risk of
developing aluminum toxicity from soy protein based formulas.
[Jatinder: 2008]

Indications for use: To more closely simulate breast milk composition and to provide
additional supplementation to preterm or low birth weight infants.

Example: Many formulas highlight some of these components, including Similac
OptiGro, Enfamil Infant, and Honest Co. Organic Premium Infant

OTHER NUTRIENTS

Probiotics: Probiotics are supplements containing organisms
that change the microflora
of the host. These organisms are typically Lactobacillus, Bifidobacterium, and
Streptococcus species. The addition of probiotics to powdered infant formula has not
been proven harmful to healthy term infants. However, there is no current evidence of
clinical effectiveness and the routine use of these formulas is not recommended.

Prebiotics: Prebiotics are supplements containing a nondigestible ingredient,
usually in
the form of oligosaccharides, which selectively stimulates the favorable growth or activity
of indigenous probiotic bacteria. Human milk contains substantial quantities of prebiotics
and is preferred for infants up to 6 months of age. The addition of oligosaccharides as
prebiotics to infant formula is not unreasonable, but lacks
evidence showing clinical
effectiveness. It is not known whether their use is cost-effective. The use of prebiotics in
preventing or treating diseases in children has not been tested extensively in randomized controlled trials, but
the available evidence shows possible long-term benefit for the prevention
of atopic eczema and common infections in healthy infants. Confirmatory
studies, especially in children who are given formula that is not partially hydrolyzed, are
needed before recommendations can be made. [Dan: 2010]

Probiotics and Prebiotics in Children (AAP) reviews the known health benefits of probiotic and prebiotic products, including those added to commercially available infant
formula and other food products for children.

Formula for Term Infants

Infant formulas provide for the nutritional needs of most
non-breastfed infants less than 1 year
old. Standard formulas contain 20 Kcal/oz and 0.45 grams of
protein/oz [National: 2015] Formulas based on cow milk are appropriate for most full-term and preterm infants. The AAP
recommends that all infants be fed breast milk or iron-fortified formula for at least 12 months.
First year weight gain goals for most term infants are as follows:

Infants
with increased energy needs, history of postnatal growth restriction, or feeding difficulties may
continue on a higher caloric density feeding (24 kcal/oz). [Laili: 2010] After hospital discharge, it is unclear what represents optimal growth for the preterm infant.
Growth data should be plotted according to the infant’s age corrected for prematurity.

Formula for Older Children

Usually after age 1, children requiring supplemental or complete nutrition from a formula
are changed from an infant formula to one designed to give a
better balance of nutrition for the
older child. Although childhood formulas are recommended for children ages 1-10, it may be
appropriate to continue some teenagers, especially those
with severe disabilities, on these
formulas because they provide a better ratio of protein to overall calories. The energy and
nutrient requirements of adolescents with special health care needs vary according to their
individual metabolic rate, activity level, and medical status. The child or adolescent should routinely be monitored to ensure
adequate nutrition for growth and development and to make
adjustments for periods of stress and illness. For more
details please see Childhood Formulas for Children with Disabilities (general).

Formula for Preterm and Low Birth Weight
Babies

Increased calorie infant formulas:

Indications for use: Infants with low birth weight and for preterm infants

Indications for use: Formulated to improve metabolic outcomes in preterm infants whose
primary, long-term nutritional source is breast milk and to supply adequate protein, sodium, zinc, and
facilitate bone development. They
come in liquid or powder formulations that are added to breast milk.
Human milk fortifiers may be found in
the hospital setting; outside of the hospital setting, they typically require a prescription.

Increasing Caloric Density - General Guide

Important recipes for increasing caloric density: When infants need extra calories to grow, the medical team can provide
recipes for increasing the calories
of 20 kcal/oz formulas ("term" formulas), or for 22 kcal/oz formulas (“preterm”
formulas). Cost and ease of home preparation must be considered. Advise the caregiver
to use precise measurements (i.e., a level scoop rather than rounded) to ensure consistent
nutrition. Consult a dietician if unfamiliar with the nutritional and/or fluid requirements of
your patient. If needed, contact a local NICU or children's
hospital for advice.

Using Term Powder Formula to Increase Caloric Density

kcal/oz

Add one scoop of 20 kcal/oz powder formula to:

20

60 mL or 2 oz of water

22

55 mL of water

24

50 mL of water

26

45 mL of water

27

42 mL of water

+ Due to variations in formula composition, it is best to consult the manufacturer's website for more details. Powder is less
accurate
than liquid concentrates.
[Committee: 2013]

Do-It-Yourself Formulas

The American Academy of Pediatrics advises against making home-made infant formula due
to serious risks of infection, ingredients that may be aspirated, and intolerance, as well as
incomplete nutrition or excessive loads of certain ingredients that may be toxic. However,
families may be very interested in learning more about this
topic. One site with extensive
information is Do-It-Yourself Baby Formulas, which is based on Weston A. Price Wise
Traditions in Food, Farm, and the Healing Arts whole foods
approach to diet.

Formula Funding for Children with Chronic Conditions

Cost of formula preparations, which can vary greatly, should be
considered when choosing a specific formula. Formulas are
generally slightly cheaper if
purchased through a home care company, commissary (if a parent is in the military), or warehouses (such as Costco or Sam's
Club). Store brand and
generic formulas offer more reasonably priced options and have to meet the same basic
requirements as name brands do.

Some insurance companies have absolute exclusions regarding formulas, while others will pay
for nutritional formulas, but only after infancy, or if the formula is needed for a special
diet (e.g., malabsorption or PKU).

The
Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), for families with children under age 5, provides a limited selection of
standard formulas in its formulary and requires a medical prescription with a valid diagnosis to
provide alternative formulas. WIC does not necessarily cover all of the formula needed
by infants, so caregivers may still be responsible for purchasing some.

Medicaid will usually fund formula if it is going through a
feeding tube. Appeals may be necessary if the
formula is being taken by mouth, or is not approaching 100% of the child's caloric needs. These appeals are
often successful if the clinician knows Examples of Letters of Medical Necessity (Rifton). To aid in appealing an insurance company or Medicaid, it
is
helpful to demonstrate
that the child cannot tolerate a cheaper formula first (e.g., try PediaSure first, if the child
demonstrates intolerance, this information might help with the appeal for the more expensive
hydrolyzed formula). Also, the
diagnosis used to request the funding is important. (e.g., Medicaid may fund formula for a diagnosis of brain malformation
with oral aversions, but not for a diagnosis of autism with oral
aversions).

There are few mechanisms available to support those who fall
between the cracks. Carnation
Instant Breakfast is a cheap alternative for the child who only needs a caloric boost. A family can
apply to Hospital Foundations or charity programs to help with costs, and a non-profit
pharmacy may be able to provide formula
at a non-profit rate. Technically, the public
school system is required to supply the formula which is part of lunch (and breakfast if the child
qualifies for the free breakfast program).

Brands of Formulas

Parents often ask their doctor for advice about brands. The links, below, lead to charts that list the major brands of formula
and key differences among their ingredients. Formulations are generally 20 kcal/oz and contain iron, unless otherwise noted.
The Medical
Home Portal does not endorse a
specific brand.

Although infant formulas are required to meet the requirements of the Infant Formula Act, manufacturers’
marketing claims often are not supported by clinical evidence or evaluated by
the Food and Drug
Administration. [Belamarich: 2015] FDA approval is only required for claims regarding formulas and their
relationship to medical conditions, claims that do not reference conditions or disease (e.g., probiotics
support digestive health) do not need FDA approval. [Abrams: 2015] Insufficient evidence shows that
removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula
benefits infants with fussiness, gas, or colic. [Thomas: 2010]

Examples of store brands, most of which are manufactured by Perrigo Nutritionals, are:

Probiotics and Prebiotics in Children (AAP)Reviews the currently known health benefits of probiotic and prebiotic products, including those added to commercially available
infant formula and other food products for use in children; American Academy of Pediatrics.

For Parents and Patients

Support

Kids with Food Allergies (AAFA)Provides education and an online support community for children with food allergies; a Division of the Asthma and Allergy
Foundation of America.

Nutrition Issues and Concerns (Bright Futures) ( 1.8 MB)A Table of Selected Energy Calculations for Children and Adolescents with Special Healthcare Needs for down syndrome, spina
bifida, Prader-Willi syndrome, cystic fibrosis, and pediatric HIV infection is on page 125; American Academy of Pediatrics.

Services

Helping Hands for Special Kids provides free or reduced cost specialty formula to parents who have children with special nutritional needs or parents of
multiples.

Developmental Pediatrics

We currently have no Developmental Pediatrics service providers listed;
search our Services database for related services.

Dan W. Thomas, MD, Frank R. Greer, MD.Probiotics and Prebiotics in Pediatrics.Pediatrics.
2010;126(6).
/ Full TextThis clinical report reviews the currently known health benefits of probiotic and prebiotic products, including those added
to commercially available infant formula and other food products for use in children.